Clinical Intelligence

FDA approves Intrarosa for postmenopausal women experiencing pain during sex

Monday, November 21, 2016

The FDA has approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).

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The CenterWatch Weekly, November 21, 2016

Monday, November 21, 2016

DrugDev acquires SecureConsent

DrugDev has acquired SecureConsent, an electronic informed consent (eConsent) pro­vider, in a move that expands the company’s suite of technology offerings designed to improve the efficiency of clinical operations at investigative sites. No financial terms of the deal were disclosed.

New specialty IRB targets social science research

A major provider of clinical research support services has launched a new institutional review board (IRB) focused entirely on social science research. The Biomedical Research Alliance of New York (BRANY), a network of four medical centers with over 200 affiliated study sites, now of­fers centralized IRB services from a panel of academic experts in social, behavioral and educational research (SBER). The new SBER IRB includes epidemiologists, psychologists and social workers, and represents an expansion of BRANY’s existing IRB services.

 

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FDA grants Fast Track Designation to E2609 for Alzheimer’s

Friday, November 18, 2016

Eisai announced has received FDA Fast Track designation for the development of E2609, a Beta-secretase Cleaving Enzyme (BACE) inhibitor currently being evaluated in phase III clinical trials for early Alzheimer’s disease. E2609 was discovered by Eisai and is being jointly developed by Eisai and Biogen as a potential Alzheimer’s disease (AD) modifying treatment.

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ProMetic’s PBI-4050 IPF phase II trial shows positive results

Friday, November 18, 2016

ProMetic Life Sciences has announced positive interim results from its open label phase II clinical trial in patients suffering from idiopathic pulmonary fibrosis (IPF). In addition to demonstrating that PBI-4050 is safe and well-tolerated in patients suffering from IPF, the objective of this study was to provide early evidence of clinical benefits of PBI-4050 treatment whether used alone or in addition to either nintedanib or pirfenidone. Forty patients are enrolled in the study in 6 sites across Canada. At this time, the corporation is reporting on the first 30 patients that have completed their 12 weeks of treatment.

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Seattle Genetics receives FDA Breakthrough Designation for ADCETRIS

Friday, November 11, 2016

Seattle Genetics, a global biotechnology company, has announced that the FDA granted Breakthrough Therapy designation to ADCETRIS (brentuximab vedotin) for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma (CTCL), accounting for more than 75% of the disease.

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Cerenis Therapeutics doses last patient in CARAT phase II study

Wednesday, November 9, 2016

Cerenis Therapeutics, an international biopharmaceutical company dedicated to the discovery and development of innovative HDL (good cholesterol) therapies for treating cardiovascular and metabolic diseases, announces the dosing of the last patient in the global phase II CARAT study. CARAT is designed to assess the therapeutic efficacy of CER-001, a pre-beta HDL mimetic, in post-acute coronary syndrome (ACS) patients.

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